Comparison of Cleft Lip and Palate Between a United States Tertiary Care Center and a Guatemalan Surgical Mission: A Cohort Study of 629 Pediatric Patients and a Survey of Risk Factors

Children's Hospital of Philadelphia1 site in 1 country629 target enrollmentOctober 30, 2017

ConditionsCleft Lip Cleft Palate Cleft Lip and Palate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cleft Lip
Sponsor: Children's Hospital of Philadelphia
Enrollment: 629
Locations: 1
Primary Endpoint: Cleft phenotype
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.

Detailed Description

Demographic, surgical, and cleft type data from US patients were gathered via chart review of the electronic medical record. Data from Guatemalan patients was gathered orally from patient caregivers in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Registry

clinicaltrials.gov

Start Date

October 30, 2017

End Date

March 13, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Children's Hospital of Philadelphia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•diagnosis of isolated cleft lip and/or palate
•scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames

Exclusion Criteria

•diagnosis of a recognized medical syndrome
•medically complex defined as having major medical problems in three or more organ systems
•diagnosis of isolated midline cleft lip
•diagnosis of Tessier facial cleft
•greater than 18 years of age